[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52055-52057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13644]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0180]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Generic Clearance for the Collection of Quantitative 
Data on Tobacco Products and Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection titled Generic 
Clearance for the Collection of Quantitative Data on Tobacco Products 
and Communications.

DATES: Either electronic or written comments on the collection of 
information must be submitted by August 20, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 20, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your

[[Page 52056]]

comment will be made public, you are solely responsible for ensuring 
that your comment does not include any confidential information that 
you or a third party may not wish to be posted, such as medical 
information, your or anyone else's Social Security number, or 
confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your comments, 
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-0180 for ``Generic Clearance for the Collection of 
Quantitative Data on Tobacco Products and Communications.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Generic Clearance for the Collection of Quantitative Data on Tobacco 
Products and Communications

OMB Control Number 0910-0810--Extension

    This information collection supports Food and Drug Administration 
(FDA, us or we) programs. Under section 1003(d)(2)(D) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA is 
authorized to conduct educational and public information programs.
    Under this umbrella generic FDA's Center for Tobacco Products (CTP) 
conducts research and uses a variety of media to inform and educate 
stakeholders (e.g., the public, tobacco retailers, and health 
professionals) about the risks of tobacco use, how to quit using 
tobacco products, and FDA's role in regulating tobacco.
    To ensure that these educational and public information programs 
have the highest potential to be received, understood, and accepted by 
those for whom they are intended, CTP conducts research to understand 
and identify and develop health messages relating to the control and 
prevention of disease. In conducting such research, FDA uses 
quantitative methods for studies about tobacco products, including but 
not limited to surveys, experimental studies, quasi-experimental 
studies and the collection and analysis of digital metrics. These 
studies are used to collect information related to foundational 
research informing message development; formative pretesting of tobacco 
communication messages and other materials directed at consumers; 
understanding the impact of tobacco public education materials in the 
digital environment; awareness of and receptivity to tobacco public 
education materials; and developing and testing survey measures to 
inform future research. This type of research may involve: (1) 
assessing audience knowledge, attitudes, intentions, behaviors, and 
other characteristics for the purpose of determining the need for and 
developing health messages, communication strategies,

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dissemination strategies, and public information programs; (2) testing 
health messages, strategies, and program components while they are in 
developmental form to assess audience comprehension, reactions, and 
perceptions, as well as after they have been disseminated to consumers; 
and (3) adding to the tobacco control, public health communication, and 
regulatory science knowledge base. Quantitative studies play an 
important role in exploring areas of research and gathering information 
because they can be used to summarize a population of interest on key 
variables or reveal systematic relationships between variables.
    This foundational research has helped FDA to understand audiences 
and inform message development and the testing of messages in 
communicating the risks of tobacco use, how to quit using tobacco 
products, and FDA's role in regulating tobacco. Obtaining this 
information has allowed FDA to improve messages, materials and 
implementation strategies while revisions are still affordable and 
possible.
    The voluntary information collected serves the primary purpose of 
providing FDA information about various measures of ad performance 
including, but not limited to, message comprehension, perceived 
effectiveness, emotional responses and knowledge, attitudes, and 
behavioral intentions to assess the ability of messages, 
advertisements, and materials to reach and successfully communicate 
with their intended audiences. Additionally, this information 
collection provides FDA with insights into how to best measure public 
education message performance. Quantitative testing of messages and 
other materials with a sample of the target audience allows FDA to 
refine and assess messages, advertisements, and materials directed at 
consumers.
    In addition, quantitative information is collected under this 
umbrella generic by FDA to track changes in response to policy and 
regulatory actions and to expand the tobacco regulatory science base by 
providing information on changing behaviors, knowledge and attitudes 
about tobacco products, including post-marketing surveillance of 
tobacco products. In addition, quantitative information is collected by 
FDA to track changes in response to policy and regulatory actions and 
to expand the tobacco regulatory science base by providing information 
on changing behaviors, knowledge, and attitudes about tobacco products, 
including postmarketing surveillance of tobacco products.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                Number of
                  Activity                      Number of     responses per   Total annual           Average burden per response            Total hours
                                               respondents     respondent       responses
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Screener...................................       1,360,000               1       1,360,000  0.083 (5 minutes)..........................         113,334
Self-Administered Surveys..................         204,000               1         204,000  0.33 (20 minutes)..........................          68,000
Informed Consent/Assent....................         204,000               1         204,000  .033 (2 minutes)...........................           6,800
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    Total..................................       1,768,000  ..............  ..............  ...........................................         188,134
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
overall increase of 96,269 hours and a corresponding increase of 
1,106,692 responses. We attribute this adjustment to the number of 
study responses used during the current approval and now estimated for 
the next 3 years. A greater number of quantitative studies will be 
conducted over the next 3 years due to the need to develop new creative 
messages and content. Recent years have seen a dramatic change in 
media. With the shift to digital media, FDA must adapt to communicate 
effectively in a digital environment. As digital tobacco use 
prevention/interventions are still in their infancy, we must better 
understand the types of digital channels available. To impact public 
health outcomes, we need to understand how to reach our intended 
audience. New foundational studies are needed (including those on 
digital metrics, measurement, and implementation) to support activities 
and initiatives that will enable the public to receive evidence-based, 
timely, and clear health communication and education. As a result, we 
have adjusted our burden estimate and revised the number of respondents 
to the information collection.

    Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13644 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P